510(k) · Cleared
ClearedNutra Light Red
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nutra Luxe MD, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 20, 2014 as substantially equivalent to K110735 (Pharos Life Corporation, 2011) and 1 other predicate after a 93-day review. Its family tree reaches back 1 generation to 2010. 81 later devices descend from it.
- Decided
- Aug 20, 2014
- Review
- 93 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K101190 (2010). 2 ancestors in all. 81 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
- This deviceK141308 Nutra Light RedNutra Luxe MD, LLC · 2014
- Descendant · cites it directly · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · 2 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · 2 generations on · 46 of its ownK192295 PDT-FaceBeijing Adss Development Co., Ltd. · 2020
- Descendant · 3 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 4 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · cites it directly75descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 2 generations on58descendants
- K192295PDT-FaceBeijing Adss Development Co., Ltd. · 2020 · 2 generations on46descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 3 generations on42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 4 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101190 | Lightstim Anti-Wrinkle Otc Model Aal Otc | Led Intellectual Properties, LLC | 2010 | — |
| 0 (this device) | K141308 | Nutra Light Red | Nutra Luxe MD, LLC | 2014 | — |
| +1 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +2 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +2 | K192295 | PDT-Face | Beijing Adss Development Co., Ltd. | 2020 | — |
| +3 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +4 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 11 | 0 |
| 2025 | 33 | 0 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OHS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K110735 | Tanda Max Otc SystemSummary page 4…, Regulation Numbers: 21 CFR 878.4810 Regulatory Class: II Product Codes: OHS 3. Predicate Device The Nutra Light Red is substantially equivalent to the Tanda Max OTC (K110735)), Light for Wrinkles (K101190). 4. Device Description The NutraLuxe Red, Model NL-2212 is a device that utilizes Light Emittin… | 2011 |
| * | K101190 | Lightstim Anti-Wrinkle Otc Model Aal OtcSummary page 4…8.4810 Regulatory Class: II Product Codes: OHS 3. Predicate Device The Nutra Light Red is substantially equivalent to the Tanda Max OTC (K110735)), Light for Wrinkles (K101190). 4. Device Description The NutraLuxe Red, Model NL-2212 is a device that utilizes Light Emitting Diodes to provide LED light t… | 2010 |
What descends from it? (81)
See all 815 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
The Nutra Light Red is a non-invasive LED light device is intended/indicated for over- the –counter use
for the treatment of periorbital wrinkles, and rhytides
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141308 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141308: Nutra Light Red.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141308
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026